Newport Medical Instruments, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Newport Medical Instruments, Inc.” (first 1982, latest 2012), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 133 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 17 | 17 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (22)
Most recent Newport Medical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121891 | NEWPORT AURA VENTILATOR | CBK | 2012-11-09 | 133 |
| K111146 | NEWPORT HT70 VENTILATOR | CBK | 2011-12-01 | 223 |
| K101803 | NEWPORT E360 VENTILATOR | CBK | 2010-09-08 | 72 |
| K090888 | NEWPORT HT70 FAMILY OF VENTILATORS | CBK | 2009-11-18 | 232 |
| K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM | CBK | 2008-12-16 | 90 |
| K061094 | NEWPORT E500 WAVE VENTILATOR | CBK | 2006-07-28 | 100 |
| K053502 | NEWPORT E360 VENTILATOR | CBK | 2006-01-10 | 25 |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | BTI | 2004-12-15 | 203 |
| K041082 | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER | CAF | 2004-09-07 | 134 |
| K030780 | NEWPORT E500 WAVE VENTILATOR | CBK | 2004-01-23 | 318 |
13 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2017-03-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Newport Medical Instruments, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Newport Biosystems, Inc. (4 510(k)s)
- Newport Bio Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Newport Medical Instruments, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Newport Medical Instruments, Inc.” (first 1982, latest 2012), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Newport Medical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Newport Medical Instruments, Inc. is 134 days.
Which FDA product codes appear under Newport Medical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 17); BTI (Compressor, Air, Portable, 1); BZK (Spirometer, Monitoring (W/Wo Alarm), 1).
Next steps
- See all 23 Newport Medical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Newport Medical Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.